Safety of Psychotropic Drugs in Pregnancy and Breastfeeding
Light gray: Generally considered safe, but uncertainties may exist, e.g., for some of the drugs within a group or related to the total amount of data available Medium gray: Increased…
Safety of Psychotropic Drugs in the Elderly
© Springer International Publishing Switzerland 2016Edoardo Spina and Gianluca Trifirò (eds.)Pharmacovigilance in Psychiatry10.1007/978-3-319-24741-0_14 14. Safety of Psychotropic Drugs in the Elderly Kate L. Lapane1 , Anne Hume2, 3 , Christine Ulbricht1 and Giovanni Gambassi4 (1) Department of Quantitative Health Sciences, Division of…
Safety of Psychotropic Drugs in Children and Adolescents
Antipsychotic drug Indication FDA approval patient age (years) EMA approval patient age (years) FGAs Haloperidola Schizophrenia – ≥3b Behavioral disorders (hyperactivity, aggression) – ≥3b Gilles de la Tourette syndrome –…
Safety and Tolerability of Mood Stabilisers
Lithium N (%) Therapeutic agent toxicity 601 (2.3 %) Tremor 525 (2.01 %) Drug interaction 477 (1.82 %) Confusional state 337 (1.29 %) Completed suicide 299 (1.14 %) Drug…
Safety and Tolerability of Anxiolytics/Sedative-Hypnotics
Common Less common Rare Anxiety Muscle pain Convulsions Insomnia Vomiting Delirium Dysphoria Hyperacusis Psychotic symptoms Excitability Photophobia Delusions Poor memory and concentration Altered sensation Hallucinations Dizziness Depersonalization Mania Gastrointestinal problems…
Safety and Tolerability of Antipsychotics
Drug D2 5HT2A M H1 Alpha-1 Adverse side-effect association Reference compound Spiperone 4 – – – – EPS, tardive dyskinesia, prolactin Ketanserin – 4 – – – Rhabdomyolysis 3-quinuclidinyl-4-iodobenzilate (QNB)…
Safety and Tolerability of Antidepressants
Antidepressant class adjusted hazard ratio (95 % CI) SSRIs TCAs Others Not taking antidepressants Adverse outcomes All-cause mortality 1.54 (1.48–1.59) 1.16 (1.10–1.22) 1.66 (1.56–1.77) 1.00 Attempted suicide/self-harm 2.16 (1.71–2.71)…
The Role of Healthcare Databases in Pharmacovigilance of Psychotropic Drugs
CPRD THIN IPCI BIFAP HSD Arianna Pedianet Country/region UK UK The Netherlands Spain Italy Italy Italy Population General population, including adults and children Pediatric and adult population Pediatric population…
Pharmacovigilance in Psychiatry: An Introduction
© Springer International Publishing Switzerland 2016Edoardo Spina and Gianluca Trifirò (eds.)Pharmacovigilance in Psychiatry10.1007/978-3-319-24741-0_1 1. Pharmacovigilance in Psychiatry: An Introduction Edoardo Spina1 , Gianluca Trifirò1 and Achille Patrizio Caputi1 (1) Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy…
Adverse Drug Reactions: Definitions, Classifications and Regulatory Aspects
Year withdrawn Drug (generic name) Reason withdrawn 1982 Clomacron Hepatotoxicity (UK) 1983 Zimeldine Hypersensitivity, Guillain-Barre syndrome (worldwide) 1986 Nomifensine Hemolytic anemia (worldwide) 1991 Triazolam Depression, amnesia (UK, France, and other…
